Transdiagnostic Sleep and Circadian Treatment for Autistic Adults

Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt and optimize an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adults, who are at increased risk for mental health disorders, using a transdiagnostic approach. The knowledge gained from this study will help to address a critical need for accessible transdiagnostic sleep interventions for autistic adults, who experience a broad range of sleep and circadian problems at high rates and often lack access to specialty care treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep; Autism Spectrum Disorder; Transdiagnostic
• Intervention / Treatment: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina P Lenker, PhD; Phone Number: 280299 7175310003; Email: klenker2@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Autistic adults diagnosed with ASD.
2. Between the ages of 18 and 65 years.
3. English-speaking
4. One or more sleep or circadian problem(s) for a period of at least 3 months assessed with the Sleep and Circadian Problems Interview.

Exclusion Criteria:

1. A history of IQ < 70.
2. A history of psychotic, bipolar or seizure disorders as per medical record.
3. Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome, as per structured interview based on risk screeners.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transdiagnostic Sleep and Circadian Intervention

Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction; Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). This evidence-based intervention targets psychosocial, behavioral, and cognitive processes that maintain sleep and circadian problems. The 4 Core Modules are: establishing regular sleep-wake times and routines; improving daytime functioning; correcting unhelpful sleep-related beliefs; and maintenance of behavior change. The optional Modules are: improving sleep efficiency; reducing time in bed; dealing with delayed or advanced phase; reducing sleep-related worry/vigilance; and negotiating sleep in a complicated environment and reducing nightmares. TranS-C consists of a total of 6, 50-min sessions over six weeks.; Other Names: TranS-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional sleep health (MSH) score	Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.	baseline (pretreatment)
Multidimensional sleep health (MSH) score	Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.	posttreatment (up to 6 weeks post baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate (feasibility)	Number of participants enrolled per month over the planned recruitment period; calculated as total number enrolled divided by number of recruitment months.	up to 6 months
Participants retention rate (feasibility)	Percentage of enrolled participants who complete the final session (6 sessions). Calculated as the number who complete the final visit divided by the number enrolled, multiplied by 100.	from enrollment to session 6 (up to 6 months)
Therapist Evaluation Questionnaire (TEQ) Total Score at End of Treatment	Scores on Therapy Evaluation Questionnaire (TEQ). TEQ is a 7-item self-report scale rated 1-7, with higher scores indicating greater treatment credibility, willingness to participate, and perceived therapist warmth/competence; total score is the sum (range 7-49) or mean of all items, with higher scores reflecting more positive evaluation of therapy and therapist.	posttreament (up to 3 months from baseline)
Therapy Homework Completion Rate	Percentage of between-session therapy homework assignments completed by each retained participant. For each participant, the number of homework assignments reported as completed is divided by the number of homework assignments assigned during the treatment period, multiplied by 100 to yield a percentage. Higher percentages indicate greater adherence to assigned homework.	from first session to posttreament (up to 3 months from baseline)
Treatment Session Completion Rate	Percentage of retained participants who complete all scheduled treatment sessions. The number of retained participants who attend (or complete) every scheduled treatment session during the treatment period is divided by the total number of retained participants, multiplied by 100 to yield a percentage. Higher percentages indicate greater engagement with the treatment.	from first session to posttreament (up to 3 months from baseline)
Treatment Fidelity: Therapist Strategy Use	Percentage of prescribed TranS-C treatment strategies recorded as used on the therapist-reported fidelity checklist. For each session, therapists indicate which TranS-C strategies were delivered using a standardized checklist; the number of strategies marked as used is divided by the total number of strategies listed on the checklist, multiplied by 100 to yield a session-level fidelity percentage. Higher percentages indicate greater adherence to the TranS-C treatment protocol.	from first session to posttreament (up to 3 months from baseline)

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena; Sleep
• Other Study ID Numbers: 28767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) collected for primary and secondary outcome measures-including Multidimensional Sleep Health (MSH) scores, Insomnia Severity Index (ISI) scores, Epworth Sleepiness Scale (ESS) scores, actigraphy-derived sleep parameters (duration, efficiency, timing, regularity), therapy engagement metrics (e.g., session attendance rate, homework completion rate), treatment fidelity data (TranS-C checklist adherence), and feasibility indicators (enrollment rate, retention rate)-will be made available. Accompanying materials will include the study protocol, statistical analysis plan, informed consent form (redacted), and codebooks defining all variables and scoring algorithms (e.g., MSH composite derivation).
• IPD Sharing Time Frame: Data will be available beginning 9 months after publication of the primary trial results manuscript and ending 5 years following that publication date.
• IPD Sharing Access Criteria: Researchers may request access for meta-analyses, secondary analyses, or replication studies that align with the trial's original aims. Requests must include a statistical analysis plan and be approved by the principal investigator and study biostatistician to ensure participant privacy and scientific merit.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No